SWOG clinical trial number
S0307
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Closed
Phase
Accrual
100%
Abbreviated Title
ADJUVANT: Bisphosphonates as Adjuvant Therapy for Breast Cancer
Activated
11/15/2005
Closed
02/01/2010
Participants
Research committees
Breast Cancer
Treatment
Clodronate
Zoledronic Acid
Ibandronate
Eligibility Criteria Expand/Collapse
--Must be female;
--Histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) w/ no evidence of metastatic disease;
--Must receive standard (systemic)adjuvant therapy for their breast cancer;
--Chemotherapy, hormone therapy, or combined chemo/hormone therapy is permitted. Additional therapies are allowed including radiation therapy and biologic agents (e.g. Herceptin, Avastin, hematopoietic growth factors);
--Patients who receive biologic agents only or RT only (w/o chemotherapy and/or hormone therapy) are not eligible;
--Patients who are at such a low risk of recurrence that adjuvant therapy will not be prescribed are not eligible;
--Neoadjuvant therapy is permitted, but enrollment must occur after completion of surgery;
--May enroll prior to, simultaneously with, or after beginning adjuvant systemic therapy; patients receiving hormonal therapy alone (no chemo) or preoperative chemotherapy should be enrolled within 84 days (12 weeks) after the date of final surgical procedure;
--Patients receiving adjuvant post-operative chemotherapy may be enrolled up to 8 weeks after completion of chemotherapy;
--Additional biological therapy or RT is allowed at any time before or after registration;
--Patients who wish to submit tissue and serum for banking must consent to the procedures for collection;
--Must have a PS = 0-2;
--Must not be co-enrolled on protocols that have bone density as an endpoint;
--May be registered to any other locoregional or systemic therapy breast cancer study, including cooperative group studies, as long as the protocol does not specifically exclude co-enrollment;
--Previous bisphosphonate use for bone density OK, as long as the bisphosphonate is discontinued at the time of registration (no other forms of bisphosphonates, other than those prescribed in this study, may be used or planned during protocol treatment);
--Dental examination w/in 6 months prior to registration;
--Patients w/ skeletal pain are eligible if bone scan and/or roentgenological examination fails to disclose metastatic disease;
--Patients must not have a history of esophageal stricture of motility disorders;
--Patients w/ a history of gastroesophageal reflux disorder (GERD) are eligible, but caution should be used when administering oral bisphosphonates;
--Patients must not be pregnant or nursing, and must agree to use an effective contraceptive method while on this trial if of reproductive potential; women of child-bearing potential must have a pregnancy test performed within 72 hrs prior to initiation of treatment;
--No other malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
--Labs: serum creatinine <= 2X IULN and a calculated creatinine clearance of >= 30 ml/min w/in 7 days prior to registration, w/ no renal failure;
--Histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) w/ no evidence of metastatic disease;
--Must receive standard (systemic)adjuvant therapy for their breast cancer;
--Chemotherapy, hormone therapy, or combined chemo/hormone therapy is permitted. Additional therapies are allowed including radiation therapy and biologic agents (e.g. Herceptin, Avastin, hematopoietic growth factors);
--Patients who receive biologic agents only or RT only (w/o chemotherapy and/or hormone therapy) are not eligible;
--Patients who are at such a low risk of recurrence that adjuvant therapy will not be prescribed are not eligible;
--Neoadjuvant therapy is permitted, but enrollment must occur after completion of surgery;
--May enroll prior to, simultaneously with, or after beginning adjuvant systemic therapy; patients receiving hormonal therapy alone (no chemo) or preoperative chemotherapy should be enrolled within 84 days (12 weeks) after the date of final surgical procedure;
--Patients receiving adjuvant post-operative chemotherapy may be enrolled up to 8 weeks after completion of chemotherapy;
--Additional biological therapy or RT is allowed at any time before or after registration;
--Patients who wish to submit tissue and serum for banking must consent to the procedures for collection;
--Must have a PS = 0-2;
--Must not be co-enrolled on protocols that have bone density as an endpoint;
--May be registered to any other locoregional or systemic therapy breast cancer study, including cooperative group studies, as long as the protocol does not specifically exclude co-enrollment;
--Previous bisphosphonate use for bone density OK, as long as the bisphosphonate is discontinued at the time of registration (no other forms of bisphosphonates, other than those prescribed in this study, may be used or planned during protocol treatment);
--Dental examination w/in 6 months prior to registration;
--Patients w/ skeletal pain are eligible if bone scan and/or roentgenological examination fails to disclose metastatic disease;
--Patients must not have a history of esophageal stricture of motility disorders;
--Patients w/ a history of gastroesophageal reflux disorder (GERD) are eligible, but caution should be used when administering oral bisphosphonates;
--Patients must not be pregnant or nursing, and must agree to use an effective contraceptive method while on this trial if of reproductive potential; women of child-bearing potential must have a pregnancy test performed within 72 hrs prior to initiation of treatment;
--No other malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
--Labs: serum creatinine <= 2X IULN and a calculated creatinine clearance of >= 30 ml/min w/in 7 days prior to registration, w/ no renal failure;
Publication Information Expand/Collapse
2023
Evaluating the Utility and Privacy of Synthetic Breast Cancer Clinical Trial Data Sets
PMid: PMID38011617 | PMC number: PMC10703127
2020
Phase III Randomized Trial of Bisphosphonates as Adjuvant Therapy in Breast Cancer: S0307
PMid: PMID31693129 | PMC number: PMC7357327
PMid: PMID32306168 | PMC number: PMC8218818
2019
2018
Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials
PMid: PMID29370458 | PMC number: PMC5963502
PMid: PMID29584550 | PMC number: PMC6127026
2017
History of diabetes and outcome among participants 65 or older in SWOG clinical trials
PMid: PMID30657402 | PMC number: PMC6640843
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